Episcleral Brachytherapy for the Treatment of Wet AMD

NCT ID: NCT02988895

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2025-05-31

Brief Summary

This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.

Detailed Description

Subjects will receive a single brachytherapy treatment and 36 months of follow-up.

Conditions

Macular Degeneration, Choroidal Neovascularization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

episcleral brachytherapy

single fraction of 24 Gy Strontium90 episcleral brachytherapy

Group Type: EXPERIMENTAL

episcleral brachytherapy

Intervention Type: RADIATION

The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.

Interventions

episcleral brachytherapy

The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.

Intervention Type: RADIATION

Other Intervention Names

Strontium 90

Eligibility Criteria

Inclusion Criteria

• Diagnosis of active CNV or PCV due to nAMD
• Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
• BCVA 20/63 or worse Snellen equivalent in the study eye
• Ability to understand nature/purpose of trial and to provide informed consent
• Ability to undergo diagnostic tests and surgical interventions
• Ability to follow instructions and complete the trial including all scheduled visits and follow-up

Exclusion Criteria

• Neovascularization other than due to AMD
• Sub-foveal lesion hemorrhage obscuring >50% of lesion
• Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography
• Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
• An existing retinal pigment epithelial (RPE) tear
• Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months
• A change in anti-VEGF agent in the previous two administrations
• Anticipate a change to the anti-VEGF agent during the conduct of the study
• Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).
• Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
• High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of >26.5mm.
• Subjects with orbital structural abnormalities, such as small (axial length <21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.
• Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography
• Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)
• Type I or type II diabetes mellitus
• Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina.
• On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results.
• Patient unsuitable for IV or local anesthesia
• Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study
• Active ocular or periocular infection or intraocular inflammation
• Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts).
• Fellow eye is receiving anti-VEGF therapy
• Have received any investigational treatment for any indication in the previous 30 days
• Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salutaris Medical Devices, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

University Retina

Oak Forest, Illinois, United States

Countries

United States

Other Identifiers

SMD-201601

Identifier Type: -

Identifier Source: org_study_id